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RECRUITING
NCT07496372
PHASE3

Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)

Sponsor: HELP Therapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)

Official title: Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-04-30

Completion Date

2027-08-31

Last Updated

2026-04-03

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

HiCM-188 therapy

Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery

PROCEDURE

CABG surgery

Conventional coronary artery bypass grafting (CABG) surgery

Locations (1)

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, China